Status:
TERMINATED
Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
ClinicalTrialCenter
FerrarioDati
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
During the acute respiratory distress syndrome (ARDS), patients' response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a...
Detailed Description
ARDS patients with a PaO2/FiO2 ratio equal or below 150 mmHg (during mechanical ventilation with PEEP 5 cmH2O) will be enrolled within 24 hours from endo-tracheal intubation. To standardize lung volu...
Eligibility Criteria
Inclusion
- Eligibility inclusion criteria, according to the ARDS Berlin definition, will be assessed within the first 24 hours from the initiation of invasive mechanical ventilation:
- Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
- Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
- Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
- PaO2/FiO2 ratio≤150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O.
- Written informed consent.
- Exclusion Criteria:
- Pregnancy;
- Pneumothorax;
- Acute brain injury;
- Clinical signs of history of decompensated heart failure (New York Heart Association class 3-4 before the acute phase of the disease or documented ejection fraction\<35% or pulmonary capillary wedge pressure\>18 mmHg) or acute coronary syndrome;
- Intubation as a result of an acute exacerbation of chronic pulmonary disease: chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc;
- Clinically evident intrinsic PEEP (≥2 cmH2O) during screening visit (End-expiratory pause to achieve Flow=0);
- BMI\>35;
- BMI\<15 or body weight\<35 Kg;
- Any chronic disease requiring long-term oxygen therapy or mechanical ventilation at home;
- Neuromuscular disease of any kind;
- Severe chronic liver disease (Child-Pugh C or worse);
- Bone marrow transplantation or chemotherapy-induced neutropenia;
- History of liver or lung transplant;
- Decision to withhold life-sustaining treatment;
- Need for therapy with inhaled nitric oxide due to documented pulmonary arterial hypertension;
- Life-threatening hypoxemia deemed to require extracorporeal membrane oxygenation (ECMO);
- Presence of documented barotrauma;
- High risk of mortality within 3 months from other than ARDS (severe neurological damage, age \>85 years and cancer patients in terminal stages of the disease).
- Persistent hemodynamic instability, intractable shock (norepinephrine\>1 mcg/kg/h and/or blood lactate\>5 mmol/L and/or considered too hemodynamically unstable for enrolment in the study by the patient's managing physician).
- More than 24 hours from endotracheal intubation to the time of the screening visit.
Exclusion
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04012073
Start Date
November 1 2022
End Date
June 30 2025
Last Update
September 30 2025
Active Locations (10)
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1
Policlinico di Bari
Bari, Italy
2
Policlinico Sant'Orsola
Bologna, Italy
3
Azienda ospedaliero-universitaria Mater Domini
Catanzaro, Italy
4
SS. Annunziata hospital
Chieti, Italy